1.0 Objective: 1.1 To lay down the procedure for Operation and Calibration of Analytical Balance (ISHIDA).
2.0 Scope: 2.1 This SOP is applicable for operation and calibration of Analytical Balance in Analytical Development labs.
3.0 References: 3.1 In- house
4.1 Executive/Officer Analytical Development Shall be responsible for the operation and calibration of the analytical balance.
5.1 AD Manager: For effective implement of the SOP.
6.1 Operating Instructions:
6.1.1 Check the Spirit level of the balance given on the front side of the balance. It should be in the middle position.
6.1.2 Balance warm up time is 5 minutes for the stabilizing purpose after Power supply is “ON”.
6.1.3 For Switching On, press “On/Off” key and for switching off press “On/Off” key again from the front panel.
6.1.4 After switch ‘On’ the system will initialize and normal weight display appears.
6.1.5 The weight of any container/butter can be tarred by “zero/Tare” key and the display set to zero. The tarring range encompasses the entire weighing range of the balance. If you wish to tare a container, place this on the weighing pan. Close shield doors. Then press the → zero/Tare ← key to start tarring process. After completion of process the normal weight display on screen.
6.1.6 If a container/butter paper tarred on the balance when it is unstable, the tarring operation will be shown in the blinked display.
6.1.7 After completion of tarring, the zero display appears and balance is ready for operation.
6.1.8 Before Operating the Balance check for proper cleaning, Spirit level, Daily verification as per procedure. The above steps shall be performed at the beginning of the day or after any power failure, which lead to the shutdown of the balance for longer time. Keep the balance always in on condition for all the working shifts.
6.1.9 Place the material and record the weight.
6.1.10 After recording the weight, remove the material from pan and tare the weighing balance with the help of → zero/Tare ← key.
6.1.11 Care should be taken not to weigh above the given operating range.
6.1.12 For change the weighing mg to gram Press and hold the →Function ← key till “1 Set 1” icon display repeated press “Function” key till display Then change 1 to 2 by using “zero/Tare” key.
6.1.13 For any change then press → zero/Tare ← key and For setting save press → Function ← key and quit from this icon press → Print ← key .
6.2.1 Disconnect the balance from power supply.
6.2.2 Clean the external surface of the instrument using clean lint free cloth or soft brush.
6.2.3 Only AD analyst shall clean the internal area of the instrument with 70% IPA.
6.3 Handling of Weights:
6.3.1 Ensure that the weights used are calibrated and certified.
6.3.2 Always use forceps to place the weight on the balance pan.
6.3.3 Do not drop the weight with force on the pan of the balance, to avoid any variation in the results.
6.3.4 Weights used for calibration should be always cleaned with soft brush and wipe
with clean dry mop before & after each use.
6.4 Daily verification of balance:
6.4.1 Weighing Note:
188.8.131.52 During operation all the sliding doors of balance shall be properly closed.
184.108.40.206 Balance pan and surrounding shall be cleaned on pre and post weighting.
6.4.2 For Solid:
220.127.116.11 Take the Square pan size butter paper and keep on the middle of balance pan and tare the paper.
18.104.22.168 Take the required amount of sample to be weighed and close all the sliding doors of balance and take print as gross weight.
22.214.171.124 Carefully transfer for the material in glassware/pots without strucking the paper and put the butter paper on pan and take weight.
126.96.36.199 Subtract the tare weight from the gross weight and get it the net weight of material.
6.4.3 For Liquid:
188.8.131.52 Put the container with having dry and clean bottom pan and tare the container. (Ensure that container weight not more than 50% of maximum weighing capacity of balance).
184.108.40.206 Take the required amount of sample in container to be weighing and close all the sliding doors of balance and take print as net weight and remove the container.
6.5 Verification (Daily):
6.5.1 Check the sprit level, if not levelled adjusts the level with the help of sprit level indicator and using levelling screw situated at the base of the instrument.
6.5.2 Perform internal calibration by press relative key.
6.5.3 Minimum weight for verification range shall be 2000 × standard deviation of uncertainty measurement.
Note: In the pharma industry, the general chapters (GC) <41> and <1251> of the USP are widely recognized as standards for managing balances, and how a minimum weight is calculated is also stipulated in these chapters.
According to the general chapters <41> “Balances”, a balance used for samples that necessitate accurate weighing must be
calibrated over the operating range and meet requirements defined for repeatability and accuracy
6.5.4 In case of working range, maximum range shall be about 80% of the balance capacity.
6.5.5 Place the standard weight one by one in the centre of the platform of the balance and record the observation in “Balance Verification Record” refer Annexure-II.
6.5.6 If balance is moved from one place to another place, calibration shall be performed & verify the balance prior to use
6.5.7 If observation are out of tolerance limit, affix “Under maintenance” label along with sign, date and discontinue the use of balance.
6.5.8 Inform engineering department or service engineer for corrective action.
6.5.9 Acceptance Criteria: Should be not more than 0.1% of reported standard value of respective standard weight or least of the balance whichever is higher.
6.6 Calibration (Monthly): Frequency ± 3 days
6.6.1 Following parameters shall be performed while performing calibration
• Linearity Test
• Uncertainty Measurement
• Eccentricity Test
220.127.116.11 Check the accuracy of the balance using standard weight mentioned against the capacity of the balance.
18.104.22.168 Place the standard weights one by one in the centre of the platform of the balance and record the observation in the balance calibration record as per Annexure III.
22.214.171.124 Acceptance Criteria: Should be not more than 0.1% of repeated standard value of respective standard weight or least of the balance whichever is higher.
6.6.3 Linearity test:
126.96.36.199 Linearity refers to the ability to deliver identical sensitivity throughout the weighing capacity of a balance.
188.8.131.52 Put the following weight in the centre of the weighing pan of balance as 100 mg, 500 mg, 1g, 5g, 50g, and 200g and record the observation of each weight.
184.108.40.206 Plot a graph of actual weight against observed weight.
220.127.116.11 Acceptance Criteria: The correlation coefficient should not be less than 0.999.
6.6.4 Uncertainty measurement:
18.104.22.168 Perform uncertainty measurement on 5.0g.
22.214.171.124 Weigh selected standard weight for 10 time and record the observation in annexure-II
126.96.36.199 Calculate mean and standard deviation from above data.
188.8.131.52 Calculate uncertainty for all the selected weight by using following formula:
184.108.40.206 Acceptance criteria: Uncertainty is satisfaction if 2 × standard deviation divided by the actual mass value, does not exceed 0.10%
220.127.116.11 If the standard deviation obtained is less than 0.41d, where‘d’ is the scale interval, replace this standard deviation with 0.41d. In this case uncertainty is satisfaction if 2 × 0.41d, divided by the actual mass value, does not exceed 0.10%
6.6.5 Eccentricity test:
18.104.22.168 Eccentricity usually is expressed as the largest magnitude of any of the deviation between an off centres reading for a least load.
22.214.171.124 Place standard selected weight (50.0g) centrally on the pan and note down the result =R(1)
Place standard at point 2, 3, 4, 5 and note down the result = R (2) …….R (5)
Subtract value R (1) from following R (2)……. R (5)
Maximum deviation of calculated difference is maximum differential centricity error.
Example of centricity error differential calculation.
Formula E= R (i) – R (1) with E= eccentricity differential error
R (i) = following point indication
R (1) = central location indication.
R (1) = 50.0003 g
R (2) = 50.0001 g
R (3) = 50.0004 g
R (4) = 50.0007 g
R (5) = 50.0003 g
E (2) = 50.0001-50.0003 = -0.0002
E (3) = 50.0004-50.0003 = 0.0001
E (4) = 50.0007 –50.0003 = 0.0004
E (5) = 50.0002-50.0003 = -0.0001
In this case, maximum differential eccentricity error is equal to approx. 0.0008 g.
126.96.36.199 Acceptance criteria: NMT 0.05 %
188.8.131.52 Place the weight (30% of balance capacity or possible integer up to 30% of balance capacity as mentioned in the balance calibration record).
184.108.40.206 If all the parameters fall within acceptance limit, affix the calibration status label.
220.127.116.11 If any observation is out of limit, affix “under maintenance” tag and discontinue use of balance.
18.104.22.168 Inform service engineer or maintenance department for corrective action.
22.214.171.124 After corrective action if balance is in working condition, recalibrate the balance prior to start the activity.
126.96.36.199 No repairs shall be done by other person except qualified maintenance person or service engineer.
SOP : Standard Operating Procedure
No. : Number
Dept. : Department
AD : Analytical Development
% : Percent
SD : Standard Deviation
g : Gram
LCD : Liquid Crystal Display
mg : Milligram
Min. : Minimum
Max. : Maximum
IHS : In house specification
8.1 Annexure I : Analytical Balance Log book.
8.2 Annexure II : Daily Verification Record of Analytical Balance.
8.3 Annexure III : Calibration Record of Analytical Balance.
Annexure Will be provided shortly